药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/12/27 – 2023/01/02
- New acceptances this week
- 387
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
387filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 213 |
| Generic | 82 |
| New drug | 72 |
| Import | 9 |
| Unspecified | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| TCM | 62 |
| 治疗用生物制品 | 38 |
| Biologic | 4 |
| 体外诊断试剂 | 1 |
| 预防用生物制品 | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 棕榈酸帕利哌酮注射液 | 5 | 1 | 8 |
| 2 | 盐酸艾司洛尔注射液 | 3 | 3 | 3 |
| 3 | 克林霉素磷酸酯注射液 | 3 | 1 | 4 |
| 4 | 注射用盐酸瑞芬太尼 | 3 | 1 | 2 |
| 5 | 西格列汀二甲双胍缓释片 | 3 | 1 | 14 |
| 6 | 钆布醇注射液 | 3 | 1 | 8 |
| 7 | 钆特酸葡胺注射液 | 3 | 1 | 1 |
| 8 | 维格列汀片 | 2 | 2 | 0 |
| 9 | 西格列汀二甲双胍片（Ⅱ） | 2 | 2 | 3 |
| 10 | 马昔腾坦片 | 2 | 2 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北朗德药业有限公司 | 32 | 16 | 0 |
| 2 | Fresenius Kabi Deutschland GmbH | 24 | 2 | 0 |
| 3 | 国大（黑龙江）制药科技有限公司 | 15 | 15 | 0 |
| 4 | 西安汤臣制药有限公司 | 8 | 5 | 0 |
| 5 | 启元生物（杭州）有限公司 | 8 | 1 | 0 |
| 6 | 宜昌人福药业有限责任公司 | 7 | 3 | 6 |
| 7 | 吉林特研药业有限公司 | 5 | 5 | 0 |
| 8 | 江西心正药业有限责任公司 | 5 | 5 | 0 |
| 9 | 绿叶嘉奥制药石家庄有限公司 | 5 | 1 | 5 |
| 10 | 内蒙古孟和制药股份有限公司 | 4 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/01New drug · Class 2.1;2.2 | 泰它西普注射液CXSL2200641 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/12/31Import · Class 2.4 | Ganaxolone口服混悬剂JXHL2200354 | Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2022/12/31Generic · Class 3 | 二羟丙茶碱注射液CYHS2202175 | 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2022/12/31Generic · Class 3 | 盐酸艾司洛尔注射液CYHS2202174 | 江苏正大丰海制药有限公司 |
| 2022/12/31New drug · Class 2.2;2.3 | 淫羊藿苷元胶囊CXZL2200057 | 山东新时代药业有限公司 |
| 2022/12/31New drug · Class 2.2 | 替雷利珠单抗注射液CXSS2200095 | 广州百济神州生物制药有限公司; 勃林格殷格翰生物药业（中国）有限公司 |
| 2022/12/31New drug · Class 1 | CM355CXSL2200640 | 北京天诺健成医药科技有限公司 |
| 2022/12/31New drug · Class 1 | 注射用RS2102CXSL2200639 | 瑞石生物医药有限公司 |
| 2022/12/31New drug · Class 1 | 注射用MHB036CCXSL2200638 | 明慧医药（杭州）有限公司 |
| 2022/12/31New drug · Class 1 | C5252疱疹病毒注射液CXSL2200637 | 深圳市亦诺微医药科技有限公司 |
| 2022/12/31New drug · Class 1 | IO-108注射液CXSL2200636 | 以明生物医药科技（杭州）有限公司 |
| 2022/12/31New drug · Class 1.3 | 重组乙型肝炎疫苗（汉逊酵母，CpG和铝佐剂）CXSL2200635 | 远大赛威信生命科学（南京）有限公司 |
| 2022/12/31New drug · Class 1 | 注射用MHB088CCXSL2200634 | 明慧医药（杭州）有限公司 |
| 2022/12/31New drug · Class 2.2 | 注射用维迪西妥单抗CXSL2200633 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/12/31New drug · Class 2.2 | 注射用维迪西妥单抗CXSL2200632 | 荣昌生物制药（烟台）股份有限公司 |
| 2022/12/31New drug · Class 1 | BEBT-305片CXHL2200991 | 广州必贝特医药股份有限公司 |
| 2022/12/31New drug · Class 1 | BEBT-305片CXHL2200990 | 广州必贝特医药股份有限公司 |
| 2022/12/31New drug · Class 1 | HX101胶囊CXHL2200989 | 华夏生生药业（北京）有限公司 |
| 2022/12/31New drug · Class 1 | RJ4287片CXHL2200988 | 南京奥利墨斯医药科技有限公司 |
| 2022/12/31New drug · Class 1 | RJ4287片CXHL2200987 | 南京奥利墨斯医药科技有限公司 |
| 2022/12/31New drug · Class 1 | QY211凝胶CXHL2200986 | 启元生物（杭州）有限公司 |
| 2022/12/31New drug · Class 1 | QY211凝胶CXHL2200985 | 启元生物（杭州）有限公司 |
| 2022/12/31New drug · Class 1 | QY211凝胶CXHL2200984 | 启元生物（杭州）有限公司 |
| 2022/12/31New drug · Class 1 | QY211凝胶CXHL2200983 | 启元生物（杭州）有限公司 |
| 2022/12/31New drug · Class 1 | 伊匹乌肽滴眼液CXHL2200982 | 益承康泰（厦门）生物科技有限公司 |
| 2022/12/30Generic · Class 3 | 地氯雷他定口服溶液CYHS2202164 | 乐信乐美（海南）生物科技有限公司; 湖南九典制药股份有限公司 |
| 2022/12/30Generic · Class 3 | 普瑞巴林口服溶液CYHS2202161 | 健民药业集团股份有限公司 |
| 2022/12/30Generic · Class 3 | 碳酸氢钠林格注射液CYHS2202157 | 回音必集团江西东亚制药有限公司 |
| 2022/12/30Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2202154 | 江苏远恒药业有限公司 |
| 2022/12/30Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2202153 | 江苏远恒药业有限公司 |
88 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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